FDA Gives Nod to Amitiza

The FDA has approved Amitiza for the treatment of Irritable Bowel Syndrome with Constipation. Since the FDA yanked Zelnorm off the market, patients with IBS have been lacking access to quality treatments.

Amitiza will be marketed by Takeda under license from Sucampo Pharmaceuticals.

Source: FDA

Adverse Events Public Service Announcement

Given all of the safety concerns with pharmaceuticals (and as a public service to the readers of this blog), I have complied a list of some of the rarer adverse events associated with pharmaceutical products. This list has been compiled from FDA reports, media stories and blog postings. A big special thanks to Public Citizen, which aided in the compilation of this list.

SSRIs (namely Pfizer’s Zoloft) is allegedly linked to gender identity disorder. After initiating therapy, some patients feel strong and compelling urges to change sexes. Of course, Zoloft is also linked to homicides (a.k.a., the Christopher Pittman defense).

Bone Disorder Drugs (such as Eli Lilly’s Evista) are linked to Restless Leg Syndrome. But thankfully we have Requip for that. Unfortuantely GSK’s Requip is linked to hallucinations. So, you can live with bone loss or take the cocktail, have shaky legs, and think the aliens are talking to you.

The entire class of estrogen containing HRT products (Wyeth’s Premarin, Vagifem, Femring, FemHRT, etc.) reportedly cause the graying or greening of toenails.

BMS’ old Buspar causes tinnitus. That’s no surprise, it’s in the label. But some patients claim the drug makes them hear voices…in foreign languages.

Thankfully, for those who hear voices, there’s Eli Lilly’s Zyprexa. Unfortunately, Zyprexa reportedly causes the voices to start singing old Neil Diamond songs.

Merck and Schering-Plough’s Zetia produces a strong, uncontrollable cough in a very small number of patients. Most of those patients live in Buffalo, New York, but it’s gotta be the drug’s fault, right?

Remember - all medications carry some risks. If something unusual happens to you, pick up the phone and immediately call a lawyer (even before seeking medical treatment).

This message brought to you by the Association of Trial Lawyers of America (now d.b.a. as the American Association for "Justice").

Oncology Pubs Find New Home

The American Journal of Hematology/Oncology and Oncology Nursing News have found a new home with UK-based Haymarket Medical. Haymarket also publishes pharma mag MM&M and PR Week.

Interestingly, oncologists are one of the few specialties that still read medical journals (probably since the science is changing so significantly). Or rather, still have the time to read journals.

IMS Says Global Pharma Growth Slows

This morning, IMS Health announced that the global pharmaceutical market grew just 6.4 percent in 2007, compared to 11.5% back in 2000. Worldwide sales now top $712 billion, compared to $365 billion back in 2000.

Highlights of the IMS Health announcement include:

• U.S., the largest pharmaceutical market (45.9% of total worldwide sales), had sales of $286.5 billion in 2007, but accounted for only a quarter of the growth globally. U.S. growth is an anemic 4.2%


• Latin American sales jumped 11.6% reaching $65.2 billion


• Japan, the second largest market, had growth of only 3.6%


• Europe now registers sales of $221.6 billion, with exception growth coming in Russia at 20.2% and Turkey at 17.2%


• Asian markets experienced significant growth of 13.3%. China grew by 25.7%, Korea at 10.7% and India at 13.0% in 2007

Takeda Buys Millennium

Takeda Pharmaceuticals of Japan is buying Millennium Pharmaceuticals of Boston for $8.8 billion (or $25 a share). This is Takeda’s second major move in a matter of weeks. The Japanese giant recently agreed to buy out Abbott’s stake in their joint venture – TAP Pharmaceuticals.

Takeda has tried for several years to grow its U.S. business organically. The efforts were dismal failure and the company has begun a new strategy of growth by acquisition.

The Millennium acquisition likely makes sense – if Millennium’s pipeline is as robust as they claim it is.

This deal makes more sense than AstraZeneca’s acquisition of MedImmune (see AstraZeneca buys MedImmune, huh?)

Pfizer’s Global Smokeout

Pfizer has a great advertising campaign going in Europe for Champix (varenicline). As countries in Europe have enacted smoking bans, Pfizer has erected outdoor ashtrays encouraging smokers to go to the doctor.

It’s a valuable public service (keeping cigarette butts off the ground), while offering smokers a chance to improve their health.

Who says drug companies can’t do good in this world?